A Multicenter Randomized Controlled Clinical Study With WeiYuan Tai (a Nutritional Supplement) on Nutritional Support of Enhanced Protein in Severe Patients(Tai Shan)
试验速览
- 阶段
- 不适用
- 入组人数
- 180
- 主要终点
- urea nitrogen of 24h
研究概览
简要总结
This is a prospective randomized controlled trial. 180 patients with critical illness will be included and randomly divided into two groups. In the control group, patients will be fed with basic energy; and in the experiment group, the patients will be given extra protein intake except the basic energy intake. The intervention duration will last 6 days. The primary outcomes of this study are urea nitrogen of 24h and prealbumin(PA). And other outcomes include nutritional status, safety indicators and clinical indicators.
详细描述
Critical illness patients are commonly in the risk of malnutrition, because of various factors. And nutritional supplement, particularly the supplement of protein, can decrease the nitrogen balance, improve the nutritional status, accelerate the speed of healing and decrease the mortality rate. This is a multi center prospective randomized controlled trial. 180 patients with critical illness will be included and randomly divided into two groups. In the control group, patients will be fed with basic energy; and in the experiment group, the patients will be given extra protein intake except the basic energy intake. The intervention duration will last 6 days. The primary outcomes of this study are urea nitrogen of 24h and prealbumin(PA). And other outcomes include nutritional status(total protein, albumin, grip and calf circumference), safety indicators(liver function, kidney function, tolerance, etc.) and clinical indicators(overall complication rate, length of hospital stay and cost).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •diagnosed as critical illness, stayed in ICU;
- •score of M-nutric ≥ 5;
- •APACHE Ⅱ >12;
- •anticipation of length of hospital stay > 6 days;
- •18 ≤ age ≤ 45;
- •pattens volunteer to attend this study and sigh the inform consent form;
排除标准
- •liver function(AST/ALT) of blood test ≥ 2.5 ULN(upper limit of normal); renal function of blood test > 1.6 ULN;
- •the patients are used or are planned to use the Human Albumin solution within 3 days before receiving enteral nutrition;
- •consume any natural food or something made by natural food;
- •patients are used or are planned to use all-in-one solution or amino acid solution within 3 days before receiving enteral nutrition;
- •anticipation of survival time is less than 5 days;
- •have the contraindications of enteral nutrition;
- •patients are allergic to material of the production;
- •patients who are considered not suitable for this study by investigators;
结局指标
主要结局
urea nitrogen of 24h
时间窗: day6
the total amount of urea nitrogen in 24 hours
prealbumin(PA)
时间窗: day6
the level of prealbumin in blood
次要结局
- liver function(day6)
- overall complication rate(from the day receiving enteral nutrition to day6)
- length of hospital stay(from date of admission in the hospital until the date of discharge, up to 1 year)
- cost in hospital(from date of admission in the hospital until the date of discharge, up to 1 year)
- renal function(day6)
- albumin(day6)
- total protein(day6)
- calf circumference(change from baseline calf circumference at 6 days)
- grip(change from baseline grip at 6 days)
研究者
Wei Chen
Principal Investigator
Peking Union Medical College Hospital